Monocentric, randomised, double-blind, cross-over controlled study with two arms. This study aims to analyse the impact on mineralisation of Sugar Free Gum (SFG) containing CPP-ACP in healthy adults.
There is some promising evidence in the literature to support a significant favourable impact of the consumption of Sugar Free Gum (SFG) containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on tooth mineralisation and especially on the promotion of tooth remineralisation, over and above the well-established role of regular SFG, in humans. This study is a monocentric, randomised, double-blind, cross-over and controlled study. The research hypothesis is that chewing a SFG containing CPP-ACP from Recaldent will better remineralise the enamel in healthy subjects compared with regular SFG, after 2 weeks of gum chewing 5 times a day for 20 minutes within 5 minutes after each meal and snack occasion, with a CPP-ACP dose of 18.8 mg per SFG. This will be studied with an in situ model study, with palatal appliances bearing recessed (1,5mm) human demineralised enamel blocks with caries-like lesions (subsurface lesions), which should be worn 24 h a day by the subjects, including during eating and drinking (but the appliances should be removed for daily oral hygiene procedure and cleaning of the appliance itself). Each appliance will contain two types of the demineralised enamel blocks: half of the blocks will contain shallow subsurface lesions (Carbopol method) and the other half reflecting deeper subsurface lesions (hydroxy-ethyl cellulose method). Both types of lesions have been the subject of oral research interest, as both shallow and deep lesions are involved in caries genesis. Changes in mineralisation of the lesions will be assessed using Transverse Microradiography (TMR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
14
Sugar free gum without CPP-ACP, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days.
Sugar free gum with 18.8 mg CPP-ACP per gum, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days.
Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the densitometric profile of the demineralised lesion (Delta Zd) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the densitometric profile of the remineralised lesion (Delta Zr) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the change in lesion depth (LDd - LDr) after treatment measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
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Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the densitometric profile of the demineralised lesion (Delta Zd) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the densitometric profile of the remineralised lesion (Delta Zr) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compare the change in lesion depth (LDd - LDr) after treatment measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compliance to the number of chewing-gum consumption per day
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compliance to the length of chewing-gum occasion
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compliance to the number of meal and snack consumption per day
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral appliance wearing (length of appliance wearing per day)
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral hygiene compliance: number of oral procedures per day
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral hygiene compliance: weight of unused toothpaste
Comparison between the 2 groups
Time frame: After 2 weeks intervention period